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Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

NCT03740217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-06-30

No results posted yet for this study

Summary

The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.

Conditions

  • Phase 1

Interventions

DRUG

GKT137831

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • York Bioanalytical Solution

    collaborator INDUSTRY

  • Calliditas Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Yves DONAZZOLO, MD · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-02-06
Completion
2019-02-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740217 on ClinicalTrials.gov